NON-SURGICAL medical devices, such as contact lenses, and home-use products, such as thermometers and blood pressure monitors, will now have to be registered with the National Health Regulatory Authority (NHRA).

The Supreme Council for Health (SCH) has issued the new rules through a decision by SCH chairman Lieutenant General Dr Shaikh Mohammed bin Abdulla Al Khalifa which has been published in the Official Gazette.

Aimed at enhancing public safety and ensuring the quality of medical devices in the market, the regulations cover a wide range of medical devices which are classified based on their intended use and risk levels.

1. Non-Surgical Medical Devices such as contact lenses, cosmetic lasers and related tools. These are commonly used in clinics, beauty centres and by individuals.

2. Home and Low-Risk Medical Devices such as thermometers, blood pressure monitors and similar devices. The process includes submitting detailed technical documentation and evidence of compliance with international safety standards.

Only excluded from the requirements are certified devices from nine international agencies such as the FDA. However, registration fees continue to be required.

Parliament’s services committee vice-chairman MP Mohammed Al Olaiwi said now the NHRA can evaluate the safety and efficacy of medical devices before they are made available to consumers.

“The measures help prevent the sale of substandard or counterfeit products that could pose health risks. A centralised registry also allows for better tracking and monitoring of medical devices in the Bahraini market.

“Clinics using cosmetic lasers and similar devices will need to ensure their equipment is properly registered, potentially increasing compliance costs.”

Mr Al Olaiwi said the move was part of Bahrain’s broader strategy to enhance its healthcare system and regulatory framework.

“By prioritising patient and consumer safety, the country continues to set a benchmark for medical standards in the region.

“The NHRA is expected to provide further guidance on the registration process and timelines for compliance, ensuring a smooth transition for businesses and consumers alike.”

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